Data Collection
OtherData collection from study participants to characterise diagnostic and therapeutic practices.
NCT Number: NCT05814237
Acute respiratory infections (ARI) are one of the most frequent reasons for hospital admission and antibiotic use, and can be caused by a broad range of pathogens, including respiratory viruses with proven epidemic potential, e.g. influenza and coronaviruses. The POS-ARI-ER study will focus on describing the different routine diagnostic and therapeutic practices in the work-up and treatment of ARI, as well as clinical outcomes across the patient population. In addition, POS-ARI-ER aims to characterise both the adult patient population with ARI presenting to acute hospital settings in Europe, and the aetiology of ARI in these patients.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Erasme Hospital, Brussels, Belgium
The POS-ARI-ER study is a perpetual, observational study (POS), designed to provide data for clinical characterisation of acute respiratory infections (ARIs) in adults presenting to hospital settings across Europe.
Establishing the etiological cause of ARI at the time of presentation is difficult with currently available diagnostic approaches. Improvements in diagnosis and strategies for use of targeted antibiotic and antiviral treatment strategies are needed to improve patient outcomes, and to reduce selection of antimicrobial resistance (AMR) and antiviral resistance. Recent advances in routine diagnostics in secondary care settings include molecular tests that can detect multiple pathogens simultaneously, and highly sensitive and specific point of care tests that can provide attending clinicians with rapid results. However, the implementation of these technologies into routine clinical practice within hospitals, and any impact on treatment decisions or patient outcomes, has not been widely evaluated.
The aim is to accurately characterise cases of ARIs presenting to acute hospital services, such as emergency departments and acute medical assessment units, in Europe.
Characterisation will focus on identifying the routine diagnostic methods (laboratory and point of care testing) and pharmacological interventions employed by different centres in patients presenting with ARI. Data will be collected using standardised report forms that capture clinical, laboratory and prescribing information. Participants will include those who require admission to hospital, as well as patients who are discharged the same day from the emergency department or acute medical assessment unit. In addition, a subset of participants will have single upper respiratory tract research sample (e.g. nose/throat swab) obtained at enrolment (within 24 hours), for pathogen detection by molecular methods.
Describing the variations in routine practice provides a foundation both to improve patient care through currently available approaches, as well as to inform areas of focus for development of new strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Data collection from study participants to characterise diagnostic and therapeutic practices.
Time frame: Four years
Calculate the proportion of types of ARI-relevant microbiology and virology investigations performed.
Time frame: Four years
Calculate the proportion of cases receiving antibiotics, antivirals, antifungals and/or immunomodulators.
Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Maximal score using the ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised.
Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Number of days patient admitted to hospital or ICU.
Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Number of days patients receiving NIV and IMV/ECMO.
Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Total number of deaths for each ARI-related pathogen.
Time frame: Four years
Evaluate demographics of patient population with ARI.
Time frame: Four years
Evaluation of comorbidities in patient population with ARI.
Time frame: Four years
Evaluation of presenting symptoms in the adult patient population with ARI.
Time frame: Four years
Evaluation of the physiological measurements in the adult patient population with ARI.
Time frame: Four years
Detection of putative pathogens in respiratory tract samples (research upper respiratory tract sample at presentation and ARI-relevant microbiology/virology results obtained through routine clinical care).
Time frame: Last day in hospital, at death or 28 days after admission, whichever comes first.
Maximal score on ordinal scale assessed at discharge, death or at 28 days after hospital admission: 6= death, 5= hospitalisation requiring extracorporeal membrane oxygenation (ECMO) and/or invasive mechanical ventilation, 4= hospitalisation requiring non invasive ventilation (NIV) and/or high flow nasal cannula (HFNC) oxygen therapy, 3= requiring supplemental oxygen (but not NIV/HFNC), 2= hospitalisation not requiring supplemental oxygen, 1= not hospitalised, stratified by pathogen.
Contact information is provided by the study sponsor or research team.
European Clinical Research Alliance for Infectious Diseases (ECRAID)
Other
Perpetual Observational Study of Acute Respiratory Infections Presenting Via Emergency Rooms and Other Acute Hospital Care Settings
Acronym: POS-ARI-ER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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